NCT05466058

Brief Summary

Aim of the study: 1) to determine validity of palpation in detecting the site of lesion in trigger finger patients by detecting sensitivity specificity, positive and negative predictive values. Hypothesis: Sensitivity of T.F palpation will be ≥ 0.70 and Specificity of T.F palpation will be ≥ 0.70.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
186

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 20, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

July 22, 2022

Status Verified

July 1, 2022

Enrollment Period

7 months

First QC Date

July 17, 2022

Last Update Submit

July 19, 2022

Conditions

Keywords

trigger finger

Outcome Measures

Primary Outcomes (1)

  • validity of palpation in detecting the site of lesion in trigger finger patients by detecting sensitivity specificity, positive and negative predictive values

    validity of palpation in detecting the site of lesion in trigger finger patients by detecting sensitivity specificity, positive and negative predictive values

    6 month - 1 year

Study Arms (2)

cases

OTHER

Physical therapist will assess patients to detect site of pathology (A1, A2, A3, A4, A5, midpalm or wrist) then patients will be refereed to radiologist who will detect site of pathology by sonography

Diagnostic Test: palpation - ultrasonography

control

OTHER

Physical therapist will assess patients to detect site of pathology (A1, A2, A3, A4, A5, midpalm or wrist) then patients will be refereed to radiologist who will detect site of pathology by sonography

Diagnostic Test: palpation - ultrasonography

Interventions

Physical therapist will assess patients to detect site of pathology (A1, A2, A3, A4, A5, midpalm or wrist) then patients will be refereed to radiologist who will detect site of pathology by sonography

casescontrol

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetic patients will be included to this study if they have TF (cases) as clinically evaluated and refereed by orthopedist and diabetic patients not complaining of TF(control).

You may not qualify if:

  • patients with complete locked finger.
  • Ages below 18 y is .
  • Patients with any other hand pathology .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Trigger Finger Disorder

Condition Hierarchy (Ancestors)

Tendon EntrapmentTendinopathyMuscular DiseasesMusculoskeletal Diseases

Study Officials

  • Eslam Elsayed Shohda, phd, pt

    GOTHI

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eslam Elsayed Shohda, phd,pt

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
radiologist will not know if the participant has trigger finger or not.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: case control clinical trial
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr - teaching fellow

Study Record Dates

First Submitted

July 17, 2022

First Posted

July 20, 2022

Study Start

July 1, 2022

Primary Completion

February 1, 2023

Study Completion

February 1, 2023

Last Updated

July 22, 2022

Record last verified: 2022-07